AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00089674
First received: August 9, 2004
Last updated: July 11, 2014
Last verified: July 2014
Results First Received: July 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: AMG 162
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Subject Enrolled: 15-Apr-2004 Last Subject Enrolled: 29-Apr-2005

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo administered subcutaneous every 6 months for 3 years
Denosumab 60 mg Q6M Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years

Participant Flow:   Overall Study
    Placebo     Denosumab 60 mg Q6M  
STARTED     734     734  
Received Study Drug     730     726  
COMPLETED     445     467  
NOT COMPLETED     289     267  
Physician Decision                 4                 2  
Adverse Event                 23                 29  
Withdrawal by Subject                 143                 127  
Death                 43                 43  
Disease progression                 21                 23  
Ineligibility determined                 8                 10  
Lost to Follow-up                 21                 17  
Noncompliance                 7                 3  
Other                 5                 9  
Requirement for alternative therapy                 14                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo administered subcutaneous every 6 months for 3 years
Denosumab 60 mg Q6M Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Total Total of all reporting groups

Baseline Measures
    Placebo     Denosumab 60 mg Q6M     Total  
Number of Participants  
[units: participants]
  734     734     1468  
Age  
[units: Years]
Mean ± Standard Deviation
  75.5  ± 7.1     75.3  ± 7     75.4  ± 7.1  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     734     734     1468  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian     3     5     8  
Japanese     4     1     5  
American Indian or Alaska Native     2     0     2  
Other     3     0     3  
White or Caucasian     609     615     1224  
Black or African American     32     36     68  
Hispanic or Latino     81     77     158  



  Outcome Measures
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1.  Primary:   Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24   [ Time Frame: 24 months ]

2.  Secondary:   Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24   [ Time Frame: 24 months ]

3.  Secondary:   Total Hip Bone Mineral Density Percent Change From Baseline at Month 24   [ Time Frame: 24 months ]

4.  Secondary:   Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36   [ Time Frame: 36 months ]

5.  Secondary:   Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36   [ Time Frame: 36 months ]

6.  Secondary:   Total Hip Bone Mineral Density Percent Change From Baseline at Month 36   [ Time Frame: 36 months ]

7.  Secondary:   Number of Participants With Any Fracture Through Month 36   [ Time Frame: 36 months ]

8.  Secondary:   Number of Participants With a New Vertebral Fracture Through Month 36   [ Time Frame: 36 months ]

9.  Secondary:   Time to First Clinical Fracture Through Month 36   [ Time Frame: 36 months ]

10.  Secondary:   Number of Participants With Any Fracture Through Month 24   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:
Publications automatically indexed to this study:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00089674     History of Changes
Other Study ID Numbers: 20040138, HALT Prostate Cancer
Study First Received: August 9, 2004
Results First Received: July 2, 2010
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration